Financial Data and Key Metrics - Revenue for Q1 2024 was $0.5 million, up 96% YoY, driven by increased demand for the Frailty and Cognitive Impairment registry trial in the Bahamas [38] - Contract manufacturing revenue was less than $0.1 million for Q1 2024, with potential to expand to $4-5 million annually once fully operational [10][39] - Total operating expenses decreased by 8% YoY, with G&A expenses increasing to $2.2 million and R&D expenses decreasing to $2.2 million due to reduced Alzheimer's trial costs and discontinuation of the Frailty trial in Japan [40] - Net loss decreased to $4.1 million in Q1 2024 from $4.6 million in Q1 2023 [54] - Cash and cash equivalents were $2.3 million as of March 31, 2024, with $11.4 million raised in April 2024 to fund operations into Q4 2024 [54] Business Line Data and Key Metrics - Lomecel-B, the lead cellular therapy candidate, is being evaluated in three treatment areas: HLHS, Alzheimer's disease, and aging-related Frailty, with a U.S. market potential of $10-18 billion [3][4] - HLHS program is the top priority, with ELPIS II Phase 2b trial on track to complete enrollment by end of 2024 [21][30] - Alzheimer's disease program showed positive results in the CLEAR MIND Phase 2a trial, with plans to meet FDA for future clinical and regulatory strategy [22][24] - Aging-related Frailty trial in Japan was discontinued to prioritize HLHS development, with cost savings redirected to HLHS [25] Market Data and Key Metrics - HLHS program has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations, potentially leading to priority review vouchers worth over $100 million [16] - The company is expanding contract manufacturing operations, leveraging its GMP facility in Miami, which includes 3,000 square feet of clean room space [18][33] Company Strategy and Industry Competition - The company is focused on optimizing resources, reducing expenses, and prioritizing HLHS and Alzheimer's disease programs [25][34] - Longeveron is leveraging its manufacturing expertise to generate additional revenue through contract manufacturing, which could offset clinical development costs [10][33] - The company is exploring partnerships and non-dilutive funding to support further development of Lomecel-B in Alzheimer's disease [24] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the potential of Lomecel-B, citing positive data from ELPIS I and CLEAR MIND trials [29][35] - The company believes 2024 could be a transformational year, with multiple catalysts including the completion of ELPIS II enrollment and regulatory discussions for Alzheimer's disease [29][34] - Management highlighted the importance of real-world evidence from the Bahamas registry trial to guide future clinical development [17][31] Other Important Information - The company has initiated a board refreshment process, appointing new members with extensive industry experience, including Richard Kender and Dr. Roger Hajjar [26][27][42] - Longeveron plans to launch an investigational osteoarthritis registry trial in the Bahamas in Q4 2024 [9] Q&A Session Summary Question: Regulatory receptivity to Lomecel-B in HLHS and potential for accelerated approval - Management aims for full approval of Lomecel-B in HLHS, with accelerated approval as a backup plan [45] - The Phase 2 trial (ELPIS II) is a head-to-head study with 19 patients in each arm, designed to show improved right ventricular function and long-term outcomes [46][47] - The company is exploring statistical methodologies to increase the probability of success and will discuss endpoints with the FDA [48][49] Question: Regulatory guidance for Lomecel-B in Alzheimer's disease and implications for future development - Management is optimistic about the potential for Lomecel-B in Alzheimer's disease, despite existing guidelines [66] - The company plans to incorporate imaging biomarkers and clinical scales in future trials, with a focus on early Alzheimer's disease and mild dementia [67][68] - Preliminary data from the CLEAR MIND trial showed slowing of brain volume decrease and cognitive stabilization, supporting future trial designs [73][74]

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 For the transition period from to . Commission File Number: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction of Incorpo ...

Richard Kender, retired SVP of Business Development and Corporate Licensing for Merck & Co., Inc., has been appointed to the Longeveron BoardDr. Roger Hajjar, former head of R&D at Ring Therapeutics, has been nominated as a candidate for the Board, subject to election at the Company's Annual Meeting of StockholdersNeha Motwani, former managing director and senior healthcare investment banker at William Blair, Truist, and Oppenheimer and Company, also has been nominated as a candidate for the Board, subject ...

MIAMI, May 02, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will report first quarter 2024 financial results and provide a business update on Tuesday, May 14, 2024 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 5:00 p.m. ET. Conference Call Details:    Conference Call Number:  1.877.407.0789    Conference ID:  13745868    Call meTM Feature ...

MIAMI, April 25, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will participate in the Planet MicroCap Showcase, taking place May 1-2, 2024. Details for the Company's presentation:  Date:Wednesday, May 1, 2024 Time:4:30 p.m. PT Webcast:Click Here    An archived replay of the webcast will be available on the "Events & Presentations" section of the Company's website following the conference. If you wo ...

MIAMI, April 15, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it has been accepted for a Featured Research Oral Presentation to present the Company's CLEAR MIND Phase 2a study results. CLEAR-MIND is a Phase 2a randomized clinical trial evaluating Lomecel-BTM in mild Alzheimer's Disease. In addition to the clinical study results, the Company has been accepted for a poster presentation at the 2024 Alzheim ...

Longeveron Inc. (NASDAQ:LGVN) Q4 2023 Earnings Conference Call February 27, 2024 5:00 PM ET Company Participants Mike Moyer – Managing Director Wa'el Hashad – Chie Executive Officer Nataliya Agafonova – Chief Medical Officer Lisa Locklear – Chief Financial Officer Conference Call Participants Dipesh Patel – H.C. Wainwright Michael Okunewitch – Maxim Group Brad Sorensen – Zacks Research Operator Ladies and gentlemen, good afternoon, and welcome to the Longeveron Fourth Quarter and Full Year 2023 Earnings Con ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40060 LONGEVERON INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organi ...

Longeveron Inc. (NASDAQ:LGVN) Q3 2023 Earnings Conference Call November 10, 2023 8:30 AM ET Company Participants Mike Moyer - Managing Director, LifeSci Advisors, LLC Wa’el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Joshua M. Hare - Co-Founder, Chief Science Officer and Chairman Conference Call Participants Michael Okunewitch - Maxim Group Operator Greetings, and welcome to the Longeveron’s Third Quarter 2023 Earnings call. At this time, all participants are in a listen-only mode. A brief que ...

ASRM approval can lead to revenue generation years before BLA application with FDA or conditional approval by PMDA Clinical Trial in Japan (N=45) ‒ NCGG (Nagoya) and Juntendo University (Tokyo) selected as clinical sites *Frailty/Aging-Related Frailty" presently does not have a consensus definition of the indication for regulatory purposes; however, it is likely that safety as observed in the proposed Phase 2 trial in Japan combined with the US Frailty 2b study will result in ASRM approval • Previous therap ...